Vitex is a global leader in the contract manufacturing of complementary medicine. In working with us, you’ll have access to extensive commercial capabilities, scale and capacity; a fully integrated best-in-class facility based in Sydney, Australia; a wide spectrum of dosage forms manufactured on the latest state-of-art equipment available in the market today; and a partner with a vision predicated on quality, innovation and integrity.
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Quality and integrity of data is paramount at Vitex and is governed by our Quality Assurance procedures. Protocols are strictly adhered to and established investigation procedures require the evaluation of results using sound scientific reasoning including but not limited to the following areas:
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The general principles around stability testing is to provide evidence on how the quality of a material or product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light. It also provides supportive data to establish the shelf life and recommended storage conditions for the product or retest period for a material. Stability information is vital for initial product registration and/or Product Quality Review (PQR).
The study approach varies depending on the product and at Vitex we offer a comprehensive stability trial design providing scope and rationale while taking into consideration the composition of a product (for example, the closure system, the technical difficulties that may be associated with stability testing of a complex multi-ingredient complementary medicine), as well as selecting the appropriate climatic zones for the end market:
Our facilities operate in strict compliance to the Australian Standards of Pharmaceutical Good Manufacturing Practices and are stringently regulated by the Australian Therapeutic Goods Administration. All facilities are further audited by our Internal Quality Assurance Department to ensure complete compliance with the Australian code of therapeutic manufacturing.
Vitex Analytical Services provide a full suite of analytical tests to generate data which allows a definitive conclusion regarding the stability of a product. The strong method development capabilities have yielded the development and validation of successful stability indicating methods across various analytical techniques.
Reporting of stability data is performed in a timely manner and any out of specification results are acted on immediately. Reports are issued providing a summary of the study detailing any trends along with recommendations for product reformulation.
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